Pharmaceutics Division, Department of Pharmaceutical Sciences and Drug Research, Punjabi University, Patiala, Punjab, India.
Pharm Dev Technol. 2011 Feb;16(1):57-64. doi: 10.3109/10837450903479996. Epub 2009 Dec 22.
The objective of the study was to develop a mathematical model for predicting the disintegration time of fast disintegrating tablets (FDTs) by estimating the powder characteristics of powder blend prior to compression. A combination of chitosan-alginate complex and glycine in the ratio of 50:50 was used for preparing FDTs. The developed mathematical model allowed water sorption time (WST), effective pore radius (R(eff.p)) and swelling Index (SI) of powder mixture as well as tablet crushing strength to be successfully correlated with disintegration time (DT) of FDTs. The predicted model showed that disintegration time of FDTs to be directly correlated with powder characteristics and inversely correlated with tablet crushing strength. Furthermore, a correlation of 0.97 was obtained when DT of FDTs was compared with SI/(WST * R(eff.p)). This correlation was not affected by inclusion of water soluble (ondansetron hydrochloride or metaclopramide hydrochloride) or water insoluble (domperidone) drugs in the powder blend or FDTs. These observations indicated the versatility of the mathematical model in predicting the disintegration time of FDTs by evaluating the selected characteristics of the powder blends without actually preparing the FDTs.
本研究旨在开发一种数学模型，通过在压缩前估计粉末混合物的粉末特性来预测速崩片（FDT）的崩解时间。壳聚糖-海藻酸钠复合物和甘氨酸以 50:50 的比例组合用于制备 FDT。所开发的数学模型成功地将粉末混合物的吸水时间（WST）、有效孔径（R(eff.p)）和溶胀指数（SI）以及片剂破碎强度与 FDT 的崩解时间（DT）相关联。预测模型表明，FDT 的崩解时间与粉末特性直接相关，与片剂破碎强度成反比。此外，当将 FDT 的 DT 与 SI/(WST * R(eff.p)) 进行比较时，获得了 0.97 的相关性。这种相关性不受粉末混合物中包含水溶性（盐酸昂丹司琼或盐酸甲氧氯普胺）或水不溶性（多潘立酮）药物或 FDT 的影响。这些观察结果表明，该数学模型通过评估粉末混合物的选定特性而无需实际制备 FDT 即可预测 FDT 的崩解时间，具有多功能性。
